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Department of health sets out scope of PIP implant and cosmetic surgery reviews

On 24 January the Department of Health published the terms of reference for two reviews in relation to the regulation of the cosmetic surgery industry.

The first review, which will be led by the Minister for Quality, Lord Howe, will consider events in the UK when the MHRA and Department of Health learnt about the withdrawal of PIP breast implants from the market. It will look at what actions were taken by those bodies at the time and whether this action was appropriate. In deciding this, Lord Howe will look at whether they sought appropriate advice and whether this was in line with their counterparts in other jurisdictions. This review will be published at the end of March of this year.

The second review will be led by Professor Sir Bruce Keogh, the NHS Medical Director, and will look at whether the cosmetic surgery industry needs better regulation. This review will take around a year to complete and will consider issues of governance, data quality, record keeping and surveillance, as well as whether suffi cient information is provided to secure patients’ informed consent. In particular, the review will look at:

whether the regulation of the products used in cosmetic interventions is appropriate;

how best to assure patients and consumers that the people who carry out procedures have the skills to do so;

how to ensure that the organisations which deliver such procedures have the clinical governance systems to ensure the care and welfare of people who use their services;

how to ensure that people considering such interventions are given the information, advice and time for refl ection to make an informed choice;

whether there should be a statutory requirement for such organisations to off er redress in the event of harm, and if so how this could be funded;

what improvements are needed in systems for reporting patient outcomes, including adverse events, for central analysis and surveillance.

It is also likely that the review will lead to the implementation of a comprehensive register of signifi cant surgical devices.